Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD) — PAL-LIVER  

End Stage Liver Disease Clinical Trial

Official title: Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are:

Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services)

Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary).

14 Clinical Centers across US are recruited to participate in this study.

Clinical Trial Description

This is a two armed multicenter cluster randomized controlled trial (RCT), to assess the effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained hepatologist led PC). To prevent bias at the level of providers, randomization will take place at the level of clinical centers; however patients will be the unit of inference. Parallel to this cluster-RCT, a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.

To execute this project, we have identified 14 clinical centers to participate; 7 Veterans Health Administration (VHA) systems and 7 non-VHA, Academic Medical Centers.

Comparative Approaches:

1. Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person visits at initial, 1, 2 and 3 months. .

2. Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person visits utilizing the same PC checklist as utilized in Model 1. The in-person visits will occur at initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.

Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver dyads will be enrolled. ;

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

• NCT number: NCT03540771
• Study type: Interventional
• Source: Albert Einstein Healthcare Network
• Contact: Manisha Verma, MBBS, MPH
• Phone: 2154561026
• Email: VermaM@einstein.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2019
• Completion date: May 31, 2025